Effect of Visceral Manipulation on PCOS
Primary Purpose
Polycystic Ovary Syndrome
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low-calorie diet
Visceral manipulation with diet
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Polycystic Ovary Syndrome, Menstruation Disturbances, Caloric Restriction, Manipulation Therapy
Eligibility Criteria
Inclusion Criteria:
- Women having PCOS.
- 25 ≤ BMI ≤ 30 Kg/m2.
- Waist/hip ratio ≤ 0.80.
- Women experiencing irregular menstrual cycles.
Exclusion Criteria:
- Having cardiovascular diseases, diabetes mellitus, and/ or hypertension
- Having malignancy.
- Presence of reproductive disorders unrelated to PCOS.
- Presence of adrenal gland abnormalities.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Diet group
Visceral manipulation with diet group
Arm Description
Giving a low caloric diet
Giving visceral manipulation added to a low-calorie diet
Outcomes
Primary Outcome Measures
Change of menstrual complaints' severity
The total score of menstruation- specific domain of polycystic ovarian syndrome questionnaire (PCOSQ) questions, calculated using the following equation: Number of patient/ group x number of questions/ domain. That total score was then used to determine the percentage of change from severity towards the optimal function.
Secondary Outcome Measures
Change in the levels of reproductive hormones (FSH, LH, LH/FSH ratio)
Human LH and FSH enzyme linked immunosorbent assay (ELISA) kits were used to assess the level of LH and FSH in the blood sample taken from each patient.
Change in weight
A weight- height scale is used to assess body weight in kilograms.
Change in Body mass index (BMI)
BMI is measured by the equation weight (Kg)/ height (m^2)
Full Information
NCT ID
NCT05029492
First Posted
August 15, 2021
Last Updated
August 31, 2021
Sponsor
Mahitab Mohammed Yosri Ibrahim
1. Study Identification
Unique Protocol Identification Number
NCT05029492
Brief Title
Effect of Visceral Manipulation on PCOS
Official Title
Effect of Visceral Manipulation on Polycystic Ovarian Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mahitab Mohammed Yosri Ibrahim
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study was conducted to determine the effect of visceral manipulation on menstrual irregularities and hormonal profile in women with polycystic ovarian syndrome. Thirty women were randomly and equally assigned into the group (A) (Control group), who received a low caloric diet (1200 Kcal/day) only for 3 months, and the group (B) (Study group), who received visceral manipulation to the pelvic organs and the related structures in addition to the same low-calorie diet as the group (A). Evaluations pre and post-study were done for body weight, BMI, female reproductive hormones, and menstruation-related problems.
Detailed Description
The current study was conducted to determine the effect of visceral manipulation on menstrual irregularities and hormonal profile in women with polycystic ovarian syndrome (PCOS). Thirty women having PCOS were chosen from the outpatient clinic of the faculty of physical therapy, Cairo University. Patients were randomly assigned into two groups equal in number. Group (A) (Control group), 15 PCOS women received a low caloric diet (1200 Kcal/day) for 3 months, while group (B) (Study group), 15 PCOS women received visceral manipulation to the pelvic organs and the related structures (8 sessions, once per week in the first month then once every other week for two months) in addition to the same low-calorie diet as the group (A). Evaluations pre and post-study for body weight, body mass index, female reproductive hormones [luteinizinghormone (LH), follicle-stimulating hormone (FSH) and LH/FSH ratio] and menstruation-related problems were done by weight- height scale, blood analysis, and menstruation-specific domain of polycystic ovary syndrome health-related quality of life questionnaire (PCOSQ), respectively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
Polycystic Ovary Syndrome, Menstruation Disturbances, Caloric Restriction, Manipulation Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Polycystic ovarian women were assigned to either group (A), receiving a low-calorie diet for three months, or group (B), receiving the same diet as group (A) together with visceral manipulation of the pelvic organs and their related structures for the same study period (three months).
Masking
Outcomes Assessor
Masking Description
an independent researcher assigned the participants to one of the two study groups, by opening sealed envelopes containing serially ordered numbers. An independent assessor analyzed the patients' blood samples for hormonal profile and another assessor blinded to patients' allocation interviewed the patients for the questionnaire and assessed the weight.
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diet group
Arm Type
Active Comparator
Arm Description
Giving a low caloric diet
Arm Title
Visceral manipulation with diet group
Arm Type
Experimental
Arm Description
Giving visceral manipulation added to a low-calorie diet
Intervention Type
Other
Intervention Name(s)
Low-calorie diet
Other Intervention Name(s)
Control group, Group (A)
Intervention Description
Low-calorie diet of 1200 kcal for 3 months, modified every two weeks.
Intervention Type
Other
Intervention Name(s)
Visceral manipulation with diet
Other Intervention Name(s)
Study group, Group (B)
Intervention Description
Visceral manipulation to the pelvic organs and their related structures (8 sessions, once per week in the first month then once every other week for two months) added to the same low-calorie diet as the group (A).
Primary Outcome Measure Information:
Title
Change of menstrual complaints' severity
Description
The total score of menstruation- specific domain of polycystic ovarian syndrome questionnaire (PCOSQ) questions, calculated using the following equation: Number of patient/ group x number of questions/ domain. That total score was then used to determine the percentage of change from severity towards the optimal function.
Time Frame
At baseline and after three months of the intervention.
Secondary Outcome Measure Information:
Title
Change in the levels of reproductive hormones (FSH, LH, LH/FSH ratio)
Description
Human LH and FSH enzyme linked immunosorbent assay (ELISA) kits were used to assess the level of LH and FSH in the blood sample taken from each patient.
Time Frame
At baseline in the second day of menstruation and after three months of the intervention.
Title
Change in weight
Description
A weight- height scale is used to assess body weight in kilograms.
Time Frame
At baseline and after three months of the intervention.
Title
Change in Body mass index (BMI)
Description
BMI is measured by the equation weight (Kg)/ height (m^2)
Time Frame
At baseline and after three months of the intervention.
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
34 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women having PCOS.
25 ≤ BMI ≤ 30 Kg/m2.
Waist/hip ratio ≤ 0.80.
Women experiencing irregular menstrual cycles.
Exclusion Criteria:
Having cardiovascular diseases, diabetes mellitus, and/ or hypertension
Having malignancy.
Presence of reproductive disorders unrelated to PCOS.
Presence of adrenal gland abnormalities.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahitab Yosri, Lecturer of women's health
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Effect of Visceral Manipulation on PCOS
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